MAUDE Adverse Event Report: ALLERGAN, INC US REFRESH CONTACTS 510(K); CARMELLOSE SODIUM

Lot Number T2185

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

An initial spontaneous report from the united states was received via non-med originating from a consumer on (b)(6) 2021 who was a female patient of unknown age who experienced wrong technique in product usage process, product contamination physical, and product delivery mechanism issue following the administration of us refresh contacts 510(k) (carmellose sodium) for "unknown indication".Allergan received the report on 30-sep-2021.Medical history was not reported.Concomitant medications were not reported.No dosage information was reported for us refresh contacts 510(k) (carmellose sodium) (eye drops, solution).The lot number was reported as: t2185 (expiry date: 24-feb-2024).On an unknown date, the patient experienced "black substance released from the bottle" (product contamination physical), "it was clogged" (product delivery mechanism issue), and "pour it into another bottle she had previously finished" (wrong technique in product usage process).This case was considered non-serious.The patient confirmed that the product never dispensed from the bottle or into her eye.She is requesting reimbursement of the product and has the sample available for return.The site of manufacture quality investigation for lot number t2185 has been completed and is within specification.Laboratory tests were not reported.Medical assessment comments: if the event was to recur, it would be likely to result in injury or impairment requiring professional medical intervention to prevent permanent harm or death.

• Brand Name: US REFRESH CONTACTS 510(K)
• Type of Device: CARMELLOSE SODIUM
• Manufacturer (Section D): ALLERGAN, INC; 2525 dupont drive; irvine CA 92623 9534
• Manufacturer Contact: 2525 dupont drive; irvine, CA 92623-9534
• MDR Report Key: 12628327
• MDR Text Key: 278555282
• Report Number: 0001643525-2021-00004
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/24/2024
• Device Lot Number: T2185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1